Enforcement discretion ends for 503B outsourcing facilities compounding tirzepatide

The last piece of FDA's wind-down for compounded tirzepatide expired on March 19, 2025. From that date, outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act no longer have the agency's stated period of enforcement discretion for making, distributing or dispensing tirzepatide injection products ^[2]. State-licensed pharmacies and physicians compounding under section 503A lost their version of that protection earlier ^[2].

Tirzepatide is the active ingredient in Eli Lilly's Mounjaro, approved for type 2 diabetes, and Zepbound, approved for obesity or overweight with a weight-related condition ^[1]. FDA first added tirzepatide injection to its drug shortage list in December 2022 because of high demand, removed it on October 2, 2024, then reevaluated that decision after compounders sued ^[1]. On December 19, 2024, the agency issued a declaratory order again finding the shortage resolved, concluding that Lilly's "supply is currently meeting or exceeding demand" and that scheduled production means supply "will meet or exceed projected demand" ^[1].

How the deadlines stacked up

The December 19 order set two clocks: 60 calendar days for 503A pharmacists and physicians, ending February 18, 2025, and 90 calendar days for 503B outsourcing facilities, ending March 19, 2025 ^[1][3]. On February 11, 2025, FDA clarified that each period would run until its stated date or until the district court ruled on the compounders' preliminary injunction motion, whichever was longer ^[2]. On March 5, 2025, the court denied that motion in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.), and FDA confirmed on March 10 that the 503A period had ended and the 503B period would run to March 19 ^[2].

The practical effect is different for the two tiers. Outsourcing facilities generally cannot compound from a bulk drug substance unless that substance is on FDA's 503B bulks list or the drug is on the shortage list at the time of compounding, distribution and dispensing; tirzepatide is not on the bulks list ^[2][3]. Traditional 503A pharmacies are barred from regularly compounding drugs that are "essentially a copy" of a commercially available product, though a narrow path can remain when a prescriber documents a significant difference needed for an identified individual patient ^[2][3].

Semaglutide — the molecule in Ozempic, Wegovy and Rybelsus — was on a later timeline. FDA declared that shortage resolved on February 21, 2025, with 503A discretion set to run until April 22, 2025, and 503B discretion until May 22, 2025, or until the court ruled in a separate case, OFA v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever came later ^[2]. That puts the semaglutide 503B date roughly two months after the tirzepatide one.

Why it matters for patients

Many people have been getting tirzepatide from compounding pharmacies and telehealth platforms, often at lower cash prices than the brands. With both compounding tiers now outside the shortage exemption, the legal basis for those copies of Mounjaro and Zepbound is gone, and supply from that channel can be expected to shrink.

FDA itself acknowledged that "significant compounding of tirzepatide injection products is occurring, and that some number of patients currently receiving those products can be expected to seek Lilly's approved products at a future point when compounding is curtailed" ^[1]. The agency also said patients and prescribers may still see "intermittent localized supply disruptions" at individual pharmacies even with the national shortage resolved, because of how product moves through wholesalers and retailers ^[1].

FDA has not said it will stop policing compounded GLP-1s in other ways. The agency repeatedly noted it may still act on violations of other requirements, such as findings that a product is of substandard quality or otherwise unsafe ^[1][2]. How aggressively FDA will enforce against remaining tirzepatide compounding, and what prices or access patients will face at the brand level, is not addressed in these documents.

What happens next

• April 22, 2025: scheduled end of 503A enforcement discretion for compounded semaglutide, subject to the court's ruling in 4:25-cv-00174 ^[2].
• May 22, 2025: scheduled end of 503B enforcement discretion for compounded semaglutide, on the same condition ^[2].
• FDA said it will keep monitoring tirzepatide supply and whether the product should return to the shortage list ^[1].